Sacral Neuromodulation in Neurogenic Patients

• Conditions: Neurogenic Bladder; Neurogenic Bowel; Urge Incontinence; Overactive Bladder; Fecal Incontinence; Retention, Urinary
• Interventions: Device: InterStim II

• Registration Number: NCT05688644
• Lead Sponsor: Omri Schwarztuch Gildor

Brief Summary

The goal of this observational study is to evaluate efficacy and safety of sacral neuromodulation in neurogenic patients compared to non-neurogenic (idiopathic) patients. \[. The main question\[s\] it aims to answer are:

* determine efficacy and safety of the therapy in neurogenic patients.

* compare outcomes of the therapy to idiopathic patients.

If there is a comparison group: Researchers will compare the outcomes of the therapy between the neurogenic and non-neurogenic subset of patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-19
• Status Verified: 2023-01
• Study First Submitted: 2023-01-09
• Study First Submitted QC: 2023-01-09
• Last Update Submitted: 2023-01-09
• Study First Posted: 2023-01-18
• Last Update Posted: 2023-01-18
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients who underwent InterStim II advanced evaluation for approved indication

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Idiopathic	InterStim II	Patients without underlined relevant neurologic condition, after advanced evaluation of InterStim II
Neurogenic Patients	InterStim II	Patients with underlined relevant neurologic condition, with either neurogenic bladder or bowel, after advanced evaluation of InterStim II

Primary Outcome Measures

Name	Time	Method
Decrease of at least 50% in number of catheterizations per day	1 year
Decrease of at least 50% in number of fecal incontinence episodes	1 year
Decrease of at least 50% in number of urge urinary incontinence episodes	1 year

Secondary Outcome Measures

Name	Time	Method
Number of revision surgeries	1 year
number of follow-up visits for programming and/or troubleshooting	1 year

Trial Locations

Locations (1)

Meir Medical Center; 🇮🇱 Kfar-Sava, Israel